The present invention relates to a sideport connector for use in conjunction with standard catheterization systems and components, and, more particularly, to a connection system which provides secure connections at such sideport locations with respect to septum-type connectors.
It is very common in the treatment of hospitalized and home healthcare patients to utilize intravenous ("IV") catheters to introduce certain fluids and medications directly into the bloodstream of the patient. Such procedures are becoming more common outside of the hospital as the high cost of hospital medical care has brought about the advent of neighborhood outpatient clinics and home healthcare.
In IV catheterization, a supply fluid is maintained in a container which is located at a height higher than the patient. The catheter tubing flows from the supply container to the location of introduction (or "injection site") into the patient where it is attached to a catheter extending into the vein of the patient. This location is typically the back of the patient's hand or a vein on the inside of the arm. Typically, a needle or other stylet is first introduced to the cannula portion of the catheter and then into the skin of the patient at the desired location. The needle is then removed, leaving the cannula in place in the vein. The fluid then flows directly into the blood vessel of the patient by gravity and/or by the pressure generated by the head of the fluid above the height of the patient.
In common practice, a single fluid supply line is established by means of such IV catheterization. However, it is frequently desirable to introduce a second fluid into the bloodstream of the patient or to administer to the patient smaller doses of medication by means of manual injection. In order to avoid a second IV wound, the established IV line is usually provided with a Y-shaped connector, frequently termed a "sideport." For example, a second fluid can be merged with the first fluid by connecting the tubing of the second container at the sideport so that the two fluids mix together as they are introduced into the bloodstream of the patient through the single, downstream IV tubing. Likewise, manual injections can be administered at the sideport location in order to avoid the pain and discomfort of an injection directly into the patient.
The connection at the sideport can be one of a variety of standard type connectors such as a luer-type or septum cap connector. One advantage of the septum cap is that it permits both types of sideport connections, e.g., a second IV fluid or manual injections. The septum cap connector (also commonly referred to as a "heparin lock" or "buff cap") is comprised of a cylindrical tube which extends from a Y-shaped connector in the main IV line. The open end of the tube is provided with a rubber septum cap which is stretched over the tube or inserted within it to completely cover the opening. A beveled needle, which can either be attached to the end of an IV line or to a manual injection device, is inserted through the rubber material of the septum and into the lumen on the other side of the septum in order to permit the confluence of fluid into the main IV line. Once the needle is withdrawn, the rubber material of the septum cap is self-sealing in that the puncture area is automatically closed. Thus, the septum cap advantageously provides rapid access for injections or secondary IV attachments. The top surface of the septum can be easily cleaned and sterilized.
Although this type of connection has several advantages, it also presents a few problems. The mechanical security of the connection is poor. The needle simply is securely retained by the thin rubber sheet forming the septum cap. Patients receiving this type of IV therapy are often ambulatory thus increasing the degree of movement and motion of the IV tubing and the risk of accidental disconnection. Furthermore, long-term infusion is becoming more prevalent, again increasing the risk of disconnection. There is also a significant risk of accidental self-injection by the needle and there is no means to prevent contamination of the connection at the sideport.
Accordingly, nurses and others who must utilize this type of IV therapy typically attempt to secure the connection by means of surgical tape. However, this method has been shown to be less than desirable because it is time consuming and still does not prevent contamination. Furthermore, existing products which have attempted to solve this problem have done so by providing two separate customized connectors, one at the sideport and one on the IV tubing, which must be joined together. In other words, such previous products are not compatible with standard septum or luer connectors, but are only compatible with connectors manufactured by the same company. This is very inconvenient to the user and also increases the cost of such standard IV therapy. Other connectors are available which attach to both the sideport and the distal end of the IV tubing; however, they have proven to be awkward and cumbersome and not much of an improvement over the use of surgical tape.